New requirements for PSUR submission

From 13 June 2016, PSURs (Periodic Safety Update Reports) will no longer be submitted direct to the national Competent Authority.  Instead, it will be compulsory for PSURs to be submitted to the new Central Repository established by the EMA (European Medicines Agency).

The repository is available now!  Up until 13 June 2016, you should still submit your PSUR to the MHRA in the usual way, and you can submit to the repository as well if you wish.  After 13 June, it will be mandatory to submit only to the repository.

In addition to PSURs, the repository also holds assessment reports and additional data.

PSURs are also known as PBRERs (Periodic Benefit Risk Evaluation Report).  The report assesses the safety and effectiveness of a medicine, whether or not it is placed on the market.  For assistance with writing PSURs/PBRERs or submitting to the repository, Regulis can help.